ANTEPSIN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SUCRALFATE

Available from:

Chugai Pharma UK Ltd

ATC code:

A02BX02

INN (International Name):

SUCRALFATE

Dosage:

1 g/5ml

Pharmaceutical form:

Oral Suspension

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

sucralfate

Authorization status:

Not marketed

Authorization date:

2000-03-31

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ANTEPSIN 1 G / 5 ML
ORAL SUSPENSION
sucralfate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effect not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Antepsin Suspension is and what it is used for
2.
What you need to know before you take Antepsin Suspension
3.
How to take Antepsin Suspension
4.
Possible side effects
5.
How to store Antepsin Suspension
6.
Contents of the pack and other information
1. WHAT ANTEPSIN SUSPENSION IS AND WHAT IT IS USED FOR
The name of your medicine is Antepsin 1 g/ 5 mL Oral Suspension
(called Antepsin
Suspension in this leaflet). Antepsin Suspension contains a medicine
called sucralfate. This
belongs to a group of medicines called “Ulcer-healing” medicines.
It works by forming a
protective barrier over a stomach ulcer and helps stop further
irritation caused by stomach
acid.
Antepsin Suspension is used to treat:
•
Stomach ulcers
•
Ulcers in your bowel
•
Inflammation of your stomach lining
Antepsin can also be used to prevent bleeding ulcers in seriously ill
patients in hospital.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANTEPSIN SUSPENSION
DO NOT TAKE ANTEPSIN SUSPENSION:
•
If you are allergic (hypersensitive) to sucralfate or any of the other
ingredients of
Antepsin Suspension (listed in Section 6). Signs of an allergic
reaction include: a
rash, swallowing or breathing problems, swelling of your lips, face,
throat or tongue
•
If you are on dialysis for kidney problems
Do not take this medicine if any of the above apply to you. If you are
not sure talk to your

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Antepsin 1g/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml dose contains 1 gram sucralfate.
Each 5ml dose also contains sodium propyl hydroxybenzoate (E217) 2.0mg
and sodium methyl hydroxybenzoate
(E219) 3.75mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension
White to off-white viscous suspension with an odour of
aniseed/caramel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Antepsin is indicated in adults and adolescents over 14 years old for
the treatment of duodenal ulcer, gastric ulcer,
chronic gastritis, and the prophylaxis of gastrointestinal haemorrhage
from stress ulceration in seriously ill patients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Antepsin must not be administered intravenously.
_Duodenal ulcer, gastric ulcer, chronic gastritis:_
Adults: The usual dose is 2 grams twice daily to be taken on rising
and at bedtime, or 1 gram 4 times a day to be taken
1 hour before meals and at bedtime. Maximum daily dose: 8 grams.
Four to six weeks treatment is usually needed for ulcer healing, but
up to twelve weeks may be necessary in resistant
cases.
Antacids may be used as required for relief of pain, but should not be
taken half an hour before or after Antepsin.
Paediatric population: The safety and efficacy of Antepsin in children
under 14 years of age has not been established.
Currently available data are described in section 5.1 but no
recommendation on posology can be made.
Elderly: see below
_Prophylaxis of gastrointestinal haemorrhage from stress ulceration:_
Adults: The usual dose is 1 gram six times a day. A maximum dose of 8
grams daily should not be exceeded. Antacids
may be used as required for relief of pain, but should not be taken
half an hour before or after Antepsin.
Paediatric population
The safety and efficacy of Antepsin in children under 14 years of age
has not been established.
Currently available data are described in section 5